This is an single-blind, single-center, two-period crossover, PK profile study. Each subject will be randomized to one of two treatment sequences. Both treatment sequences will be enrolled concurrently.

A Randomized, Single-Blind, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of BG00012 Supplied by Two Different Manufacturers.

Further study details as provided by Biogen:

Primary Outcome Measures:

PK - Area under the plasma concentration curve. [ Time Frame: Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours ] [ Designated as safety issue: No ]

Peak plasma concentration as a measure of PK. [ Time Frame: Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The number of AEs in participants as a measure of safety and tolerability. [ Time Frame: Participants will be followed during the study, 4 days. ] [ Designated as safety issue: Yes ]

This is a study of healthy volunteers to demonstrate bioequivalence of one formulation of BG-00012 given in capsule form supplied by two different manufactures.

Eligibility

Ages Eligible for Study:

18 Years to 55 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Must give written and informed consent and any authorizations required by local law.

Males and females 18 - 55 years old inclusive at time of consent.

Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).

History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic,metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric and renal or other major disease, as determined by the Investigator.

Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).

Current enrollment in any other drug, biologic, or device study.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632449